Validation Activities Sample Clauses
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Validation Activities. Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products. The fees associated with Patheon’s assistance in providing validation development assistance are set out in Schedule C to a Product Agreement.
Validation Activities. Supplier shall prepare the documentation, protocols, and procedures. Supplier shall validate its pharmaceutical manufacturing processes, tests, and methods as well as associated facilities, equipment and systems, keep such processes, tests, methods, facilities, equipment and systems, keep such processes, tests, methods, facilities, equipment, and systems current, and make results of validation and annual reviews of such processes, tests, methods, facilities, equipment, and systems available on site for audit or review by Endo in accordance with the Quality Agreement.
Validation Activities. Nisso shall undertake and complete all necessary qualification and validation activities for the Nihongi Facility to manufacture and supply commercial quantities of the Drug Substance meeting the Specifications in accordance with the then-current Drug Master File for the Drug Substance and all Regulations and Regulatory Approvals. Such activities shall be undertaken in accordance with the timeline and plan set forth in Attachment 2.3 hereto (“Timeline”). Subject to Section 2.4 (Purchase of Validation Lots of Drug Substance) hereof, all costs related to such activities shall be for the sole account of Nisso. It is acknowledged by the Parties that Nisso have already commenced a part of such activities in accordance with the Letter Agreement.
Validation Activities. The Contractor’s quality program shall be examined using a series of required validation procedures. The examination shall be implemented and conducted by HCA, its agent, or an EQRO.
Validation Activities. “Validation Activities” shall mean those activities to be performed by DSM prior to the First Commercial Sale including, but not limited to, process qualification of content uniformity, analytical testing, preparation of validation technical reports, cleaning validation, manufacturing and testing of Validation Lots.
Validation Activities. Supplier shall prepare the documentation, protocols, and procedures. Supplier shall make documents available on site for audit or review by Company in accordance with the Quality Agreement.
Validation Activities. NPI will assist in the development and approval of the predicate protocols and validation reports, including design qualification protocols, validation master plans, and validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products for the fees set out in Schedule B.
Validation Activities. Supplier shall, promptly after the Initial Expansion, complete the validation of the manufacturing process and analytical methods for the Drug Substance that is associated with the Initial Expansion at no additional cost to Amarin (the “Initial Expansion Validation”). Supplier shall develop a validation protocol as soon as practicable utilizing consultation services provided by [***] and shall be suitably reviewed by [***]. Supplier shall deliver to Amarin, before and after validation, samples manufactured in the facility established by the Initial Expansion with a summary report written by [***] as soon as Supplier completes the validation activities.
Validation Activities. Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products. The fees associated with Patheon's assistance in providing validation development assistance are set out in Schedule C to a Product Agreement. (i) Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon. If it is determined by a quality investigation that Patheon manufactured Product in accordance with the agreed upon process specifications, the batch production record, and Patheon's standard operating procedures for manufacturing, but a batch or portion of batch of Product does not meet a Finished Product Specification, Client will pay Patheon the applicable fee per unit for the non-conforming Product. The API in the non-conforming Product will be included in the "Quantity Converted" for purposes of calculating the "Actual Annual Yield" under Section 2.2(a).
Validation Activities. G▇▇▇ shall be responsible for Validating all critical systems, processes, tests and equipment necessary in connection with the Manufacture of API for SAVARA under this Agreement in a timely manner as set forth in the API Specifications. Without limiting the foregoing, SAVARA shall have the right to review and approve (a) specified individual Validation protocols with respect to any processes relating to the Manufacture of API for SAVARA, prior to the implementation of the same and (b) a written process Validation report provided by G▇▇▇ to SAVARA upon completion of the Validation activities. In addition, upon completion of such Validation activities, G▇▇▇ shall provide to SAVARA all API Manufactured as a result of such Validation activities and SAVARA shall have the right to use or dispose of such quantities of API resulting for any purpose.